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BRAVE-HEARTHeart-Sparing Effect of Breast Radiotherapy with Active Breathing Coordinator

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Study Aim

This observational study aims to examine the heart-sparing effect of breast radiotherapy when used in conjunction with an Active Breathing Coordinator device in breast cancer patients.

What is being collected

Data Collection

Who is being recruted

Breast Diseases+12

+ Breast Neoplasms

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2024
See protocol details

Summary

Principal SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Study ContactElisabetta Bonzano, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 23, 2024

Actual date on which the first participant was enrolled.

The BRAVE-HEART study focuses on breast cancer patients who are undergoing radiotherapy. This study takes place at Fondazione IRCCS Policlinico San Matteo in Italy. Its main goal is to understand how a special breathing technique, called Deep Inspiration Breath Hold (DIBH) assisted by the Active Breathing Coordinator (ABC), can help protect the heart during radiation treatment. This is particularly important for patients with stage I-III breast cancer who are typically receiving radiation therapy after surgery. The study aims to show that this special breathing technique can reduce the amount of radiation that reaches the heart and potentially improve the safety of breast cancer treatment. During the study, patients receive radiotherapy using either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated/volumetric modulated arc therapy (IMRT/VMAT) techniques. These treatments can be given in various durations and intensities, with or without a simultaneous boost to the tumor bed. The study compares the radiation dose to the heart during normal breathing and during the special breathing technique (DIBH assisted by ABC). The primary goal is to measure the reduction in radiation dose to the heart and its substructures, especially the left anterior descending coronary artery (LAD). The study also evaluates the consistency of the treatment, the feasibility of using ABC-DIBH in daily practice, and collects data on any immediate and long-term side effects.

Official TitleBRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
Principal SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Study ContactElisabetta Bonzano, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsCardiovascular DiseasesHeart DiseasesNeoplasmsNeoplasms by SitePathologic ProcessesRadiation InjuriesSkin DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesSkin and Connective Tissue DiseasesChemically-Induced DisordersDrug-Related Side Effects and Adverse ReactionsCardiotoxicity

Criteria

Inclusion Criteria: * Diagnosis of stage I-III breast carcinoma with an indication for radiotherapy * Invasive carcinoma or ductal carcinoma in situ (DCIS) * Radiotherapy delivered using three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated/volumetric modulated arc therapy (IMRT/VMAT) techniques * Ability to actively cooperate in using the Active Breathing Coordinator (ABC) system for Deep Inspiration Breath Hold (DIBH), or treated under free-breathing conditions when DIBH is not feasible * Age ≥18 years * Ability to provide written informed consent for the anonymous use of data for research purposes Exclusion Criteria: * Severe health problems or profound hearing loss * Severe respiratory or cardiovascular conditions in the medical history that contraindicate radiotherapy * Inability to provide written informed consent for the anonymous use of data for research purposes * Absolute contraindications to radiotherapy (e.g., pregnancy, or inability to maintain the correct treatment position)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fondazione IRCCS Policlinico San Matteo

Pavia, ItalyOpen Fondazione IRCCS Policlinico San Matteo in Google Maps
Recruiting
One Study Center
BRAVE-HEART | Heart-Sparing Effect of Breast Radiotherapy with Active Breathing Coordinator | PatLynk